nasal spray flu shots

From Scientific American: "The Center for Disease Control and Prevention announced that the nasal spray form of the flu vaccine does not work. Preliminary research indicated that during the last flu season the spray was only 3% effective in children between the ages of two and twelve. The agency now recommends the flu shot for everyone."

Re: nasal spray flu shots

Developing therapeutics, including vaccines, is preceeded by many years if not decades of research, including extensive safety and toxicity studies. There can be exceptions, for example when small population of patients with no other therapeutic options and a desperate need for a potential therapy that outweighs potential risks exerts political pressure to get an investigational medication "fast tracked" towards the clinic (think cancer patient dying in a couple of weeks). Otherwise, the process of developing therapies, especially for children, is by no means a matter of directly testing things on them.

Developing therapeutics, including vaccines, is preceeded by many years if not decades of research, including extensive safety and toxicity studies. There can be exceptions, for example when small population of patients with no other therapeutic options and a desperate need for a potential therapy that outweighs potential risks exerts political pressure to get an investigational medication "fast tracked" towards the clinic (think cancer patient dying in a couple of weeks). Otherwise, the process of developing therapies, especially for children, is by no means a matter of directly testing things on them.

In other words, what was lacking here was efficacy, not safety.

No, I wasn't worried about the medicine being safe. I'm sure it was. My concern was what if one of these chlldren who did not get a regular flu shot came down with a very bad case of flu? That and I didn't think they were allowed to do research tests on children.

That said, you have a statement up there that may explain things. You say: "Otherwise, the process of developing therapies, especially for children, is by no means a matter of directly testing things on them."

Are you saying they have a way to test whether the medicine works on children without actually testing it on children?

When developing a new therapeutic, you start safety testing long before you get to the first human subject. First you start with biochemical testing to see if you get any red flags. Then you start testing on cells, tissues, and eventually animals. After that, you start testing on a very small number of human subjects at very small doses. Then you escalate the doses gradually until you start seeing signs of potential toxicity. If no efficacy can be seen well before such signs begin to appear, the clinical trial is stopped and the project is killed.

When you put a new therapy out, the first thing you need to make sure is that it is safe and that the side effects are manageable. To manage the risk, you start with a very small number of people, and you increase the size of the sample as you get more and more indications that the therapy is safe. However, the only real test on how the entire population will respond to a therapy is when the entire population starts to use it. Thus, there are things that just cannot be learned or predicted until the therapeutic is on the market. That's why some get pulled off the market after a while if the population data comes back different from the statistical data of the clinical trial. In this case, for example, the efficacy of the vaccine when applied at large ended up being much lower than when tested in the clinical trial. This could be due to many reasons, which are not necessarily related to the therapeutic itself. For example, it could just be that the storage method is complicated, or that administering the therapy in real life scenario doesn't always go as well as it did in the controlled environment of the clinical trial, and so on. No matter the case, however, if not enough efficacy is observed, the product gets pulled off the market to either be reevaluated, or killed for good. If the low efficacy was due to a design problem, the product could come back assuming the issue could be fixed (for example if an inhaler tended to break quickly and stop delivering the right dose of medication, this could be addresses by redesigning the inhaler itself). If the issue is due to the drug itself, it usually goes away forever. Though there can be exceptions, for example if some new formulation is discovered that significantly increases the drug's efficacy, or if the drug is found to be effective for a different indication and can be safely repurposed for it.

None of this, as experience tells us, is fail safe. But it does systematically lower the risk while increasing the benefit (of therapeutic discovery/development). We have way more diseases than we have therapies, so the choice should be clear.

Re: nasal spray flu shots

Thank you and I do understand. But does that answer the question (apologies for forgetting to put it in my first post) of what if a chlld who got the perfectly safe - but headed for failure in efficacy - came down with a serious case of the flu because he did not get a regular flu shot? I hesitate to say what the results might have been.

I think my question is one step beyond getting the medicine safe. It was given to children. it did not work. So far, no harm done. But then my "what if" question.

I do realize the time comes when you have to test on humans. Adults can give consent. Children cannot.

Re: nasal spray flu shots

All I can assume here is that the preliminary data in the clinic suggested comparable efficacy to warrant trying the replacement outside the clinic (I haven't looked at that data so I'll need to verify this). So then why test and applicability of the nasal spray is we already have shots that work? My guess is that giving a nasal puff to a child is probably a lot easier than giving them a shot and might get more kids vaccinated quickly.

Re: nasal spray flu shots

"The nasal spray's low effectiveness is somewhat surprising, experts say — in earlier studies, the spray performed just as well as, and sometimes better than, the flu shot. The nasal spray contains live, weakened flu viruses, which, in theory, can produce a stronger immune response than the killed flu viruses that are in the flu shot, the CDC said."

There's speculation that the differential efficacy might. e strain specific. But that hasn't been demonstrated yet.

"It's important to note that the new recommendation against using the flu nasal spray is only for the upcoming 2016 to 2017 flu season, Adalja said. After that, the CDC will need to review new data to see if it will keep or change this recommendation."

"The nasal spray's low effectiveness is somewhat surprising, experts say — in earlier studies, the spray performed just as well as, and sometimes better than, the flu shot. The nasal spray contains live, weakened flu viruses, which, in theory, can produce a stronger immune response than the killed flu viruses that are in the flu shot, the CDC said."

There's speculation that the differential efficacy might. e strain specific. But that hasn't been demonstrated yet.

"It's important to note that the new recommendation against using the flu nasal spray is only for the upcoming 2016 to 2017 flu season, Adalja said. After that, the CDC will need to review new data to see if it will keep or change this recommendation."

All right. There was every reason and evidence to say the spray would work. They were not actually testing when they gave it to the children. That's a different story. Evidently Scientific American's brief paragraph was a tad off.